University of Alabama at Birmingham (UAB) Pediatric CBD Program

Inclusion Criteria

• Patients between 1 years (12 months)-18 years with drug resistant epilepsy confirmed by video EEG recording report, and
• Patient should have history of a trial of at least four anti-epileptic drugs (AEDs), including one trial of a combination of two concomitant drugs without successful seizure control. Vagal nerve stimulation (VNS), Responsive Neurostimulation (RNS) deep brain stimulation, or the ketogenic diet can be considered equivalent to a drug trial. Patient suffering from an epileptic syndrome that is known to be refractory to treatment, such as Dravet or Lennox-Gastaut Syndrome, may be included after a trial of only two drugs, and
• Between 1-4 baseline anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to submitting records for review by the CBD Treatment Approval Committee.
• VNS or RNS must be on stable settings for a minimum of 3 months.
• If on ketogenic diet, must be on stable ration for a minimum of 3 months.
• Review of the following patient medical information:
• Most recent Brain MRI report,
• Most recent ECG report,
• Video/EEG monitoring report confirming the diagnosis of epilepsy,
• Evidence that the patient has failed 4 AEDs as indicated above,
• Patient must have at least 4 clinically countable seizures per month,
• Seizure history to include a documented history of generalized (drop, atonic, tonic clonic, and/or myoclonic) seizures, focal seizures without loss of consciousness with a motor component, focal seizures with loss of consciousness, or focal seizures with secondary generalization, complex partial seizures with a motor or tonic component, and I or altered awareness seizures,
• Results of routine testing including blood work (Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), Liver Function Tests (LFTs), renal panel, Urinary Analysis (UA), and levels of all AEDs) and digital copy of a routine EEG along with the formal written report performed within 3 months prior to submitting records for CBD Treatment Approval review. If applicable, results of any metabolic or genetic testing performed should be included in submitted records for review. If any AED dose was adjusted in the preceding 3 months, level on the new dose will need to be provided.
• If applicable, documentation (including date of surgery) of prior VNS, RNS, Corpus Callosotomy, or other epilepsy surgery the patient has received.
• Acceptable method of contraception (or abstinence) for women of childbearing potential and for male patients with partners of childbearing potential, and female patients must have a negative urine pregnancy test on the day of initiating CBD.
• For patients who agree to participate in the optional neuroimaging sub-study, an MRI screen will be obtained to show that the patient does not have contraindication to receiving MRI/functional MRI (fMRI) at 3 Tesla (e.g., metallic artifact).
• Patients are able to supply investigator with seizure calendars for the past 3 months prior to submitting records for CBD Treatment Approval Committee review. The patient will need to provide an updated calendar at the time of enrollment.
• Approval for inclusion by the CBD Treatment Approval Committee.
• Current State of Alabama Resident
• Acceptable documentation of Alabama residency includes the following:
• a state issued identification (ID), such as a driver's license, from patient or patient's parent/ legally authorized representative (LAR).
• documents showing the patient or patient's parent/LAR rents/owns property in the state,
• state voter registration from patient or patient's parent/LAR, or
• a recent state tax return from patient or patient's parent/LAR.

Exclusion Criteria

• Active Psychogenic non-epileptic seizures (PNES); Patients with more than 1 year freedom from PNES will not be excluded,
• Patients who are pregnant, breastfeeding, or not using acceptable methods of contraception during the course of the study and for three months thereafter,
• Male patie